Osteosarcopenia and Exercise

NCT04526327 | Completed

• 1 other identifier: 2189
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficacy of combination of aerobic and resistive exercise on activities of daily living and risk of fall in osteosarcopenic patients

Conditions

Sarcopenia; Osteoporosis, Osteopenia

Keywords

aerobic exercise; resistive exercise; balance; falling; physical performance; osteosarcopenia

Outcome Measures

Primary Outcomes (12)

• Change from Baseline on Skeletal Muscle Mass Measurement at month 3

  Assessment with bioelectrical body composition analyzer male: SMI\<9,2 kg/m2 female: SMI\<7,4 kg/m2

  Baseline and Month 3

• Change from Baseline on Skeletal Muscle Mass Measurement at month 1

  Assessment with bioelectrical body composition analyzer male: SMI\<9,2 kg/m2 female: SMI\<7,4 kg/m2

  Baseline and Month 1

• Change from Baseline on Katz Activities of Daily Living Scale at month 3

  minimum 0, maximum 6, high scores: better

  Baseline and Month 3

• Change from Baseline on Katz Activities of Daily Living Scale at month 1

  minimum 0, maximum 6, high scores: better

  Baseline and Month 1

• Change from Baseline on Short Physical Performance Battery at month 3

  0-low perfomance, 12-good performance

  Baseline and Month 3

• Change from Baseline on Short Physical Performance Battery at month 1

  0-low perfomance, 12-good performance

  Baseline and Month 1

• Change from Baseline on Berg Balance Test at month 3

  maximum 56 point, a score of \< 45 indicates individuals may be at greater risk of falling.

  Baseline and Month 3

• Change from Baseline on Berg Balance Test at month 1

  maximum 56 point, a score of \< 45 indicates individuals may be at greater risk of falling.

  Baseline and Month 1

• Change from Baseline on Timed Up and Go Test at month 3

  Stand up and walk 3 meters, turn around, walks back to the chair and sit down.14 seconds or longer : high risk for falling

  Baseline and Month 3

• Change from Baseline on Timed Up and Go Test at month 1

  Stand up and walk 3 meters, turn around, walks back to the chair and sit down.14 seconds or longer : high risk for falling

  Baseline and Month 1

• Change from Baseline on Five Times Sit to Stand Test at month 3

  Lower times: better scores

  Baseline and Month 3

• Change from Baseline on Five Times Sit to Stand Test at month 1

  Lower times: better scores

  Baseline and Month 1

Study Arms (1)

exercise group

OTHER

Female and male patients over 70 years of age with osteoporosis and sarcopenia

Other: exercise

Interventions

exercise OTHER

the combination of aerobic and resistive exercise, three time a week

exercise group

Eligibility Criteria

• Age: 70 Years - 91 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Over 70 years of age
• Clinical diagnosis of osteoporosis or osteopenia
• Independent mobilization
• Walking speed \< 0.8 m / sec
• Grip strength \< 20 kg for women, \< 30 kg for men

You may not qualify if:

• Uncontrolled hypertension (systolic blood pressure\> 200 mmHg, diastolic blood pressure\> 110 mmHg)
• Uncontrolled diabetes mellitus
• Stroke, hip fracture, knee and hip arthroplasty, spinal surgery in the last 6 months
• Severe cardiac arrhythmia
• Myocardial infarction in the last 6 months
• Severe dementia and difficulties in cooperation
• Cardiac pacemaker
• Dialysis
• Acute infection
• Severe edema
• Malignancy patients
• Severe anemia (Hgb \<8 mg / dl)

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Şişli Hamidiye Etfal Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sarcopenia; Osteoporosis; Bone Diseases, Metabolic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Figen Yılmaz

  Şişli Hamidiye Etfal Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Female and male patients over 70 years of age followed-up from osteoporosis outpatient clinic

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 25, 2020
• Study Start: December 3, 2018
• Primary Completion: March 3, 2019
• Study Completion: October 1, 2019
• Last Updated: August 25, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)